First subcutaneous anti-PD-(L)1 cancer
immunotherapy available to patients in Great Britain
Tecentriq® subcutaneous
formulation with ENHANZE® reduces treatment time to
seven minutes compared to 30-60 minutes for standard intravenous
infusion
SAN
DIEGO, Aug. 29, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the
approval of Roche's Tecentriq® SC (atezolizumab),
using Halozyme's ENHANZE® drug delivery technology,
by the Medicines and Healthcare Products Regulatory Agency (MHRA)
in Great Britain.
Tecentriq® subcutaneous (SC) is co-formulated with
Halozyme's proprietary recombinant human hyaluronidase enzyme,
rHuPH20, allowing for subcutaneous delivery, which takes
approximately seven minutes, compared with 30-60 minutes for
intravenous (IV) infusion. Tecentriq® SC will be
available to patients in Great
Britain for certain types of lung, bladder, breast, and
liver cancer.7
Multiple oncology studies suggest that most cancer patients
prefer to receive their treatments via subcutaneous delivery,
instead of intravenous infusion because of reduced discomfort, ease
of administration, and shorter duration of
treatment.2,4,11
"We are delighted that Roche has received approval of Tecentriq
SC in Great Britain. Subcutaneous
delivery of Tecentriq provides cancer patients a faster and more
flexible treatment option and may alleviate pressure on healthcare
system resources," said Dr. Helen
Torley, president and chief executive officer of Halozyme.
"We look forward to additional regulatory approvals of our partner
products utilizing ENHANZE."
Tecentriq® SC is the first subcutaneous
anti-PD-(L)1 cancer immunotherapy available to patients in
Great Britain and is Roche's
fourth subcutaneous cancer therapy using Halozyme's
ENHANZE® drug delivery technology.8-10
The approval is based on clinical data from the Phase IB/III
IMscin001 study, which showed comparable levels of
Tecentriq® in the blood when administered
subcutaneously, and a safety and efficacy profile consistent with
the IV formulation.12 While the IMscin001 trial was
conducted within the hospital setting, the SC formulation may be
suitable for out-of-hospital administration by a healthcare
professional.
The U.S. Food and Drug Administration (FDA) is currently
evaluating Tecentriq® SC for regulatory
approval.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme
rHuPH20, Halozyme's commercially-validated solution is used to
facilitate the delivery of injected drugs and fluids in order to
reduce the treatment burden to patients. Having touched more than
700,000 patient lives in post-marketing use in six commercialized
products across more than 100 global markets, Halozyme has licensed
its ENHANZE® technology to leading pharmaceutical
and biotechnology companies including Roche, Takeda, Pfizer,
AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon
Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED®, TLANDO® and
NOCDURNA® and partnered commercial products and
ongoing product development programs with several pharmaceutical
companies including Teva Pharmaceuticals and Idorsia
Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect
with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's
ENHANZE® drug delivery technology including the possible
benefits and attributes of ENHANZE®, the possible method
of action of ENHANZE®, its potential application to aid
in the dispersion and absorption of other injected therapeutic
drugs, facilitating more rapid delivery and administration of
higher volumes of injectable medications through subcutaneous
delivery and certain other benefits of
ENHANZE® including lowering the treatment burden
for patients and alleviating pressure on health care system
resources, including potential out-of-hospital administration of
Tecentriq® SC. Forward-looking statements regarding the
Company's ENHANZE® business may include potential
growth driven by our partners' development and commercialization
efforts (including anticipated regulatory submissions, PDUFA dates,
potential regulatory approvals, indications and product launches).
These forward-looking statements are typically, but not always,
identified through use of the words "believe," "enable," "may,"
"will," "could," "intends," "estimate," "anticipate," "plan,"
"predict," "probable," "potential," "possible," "should,"
"continue," and other words of similar meaning and involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. Actual results could
differ materially from the expectations contained in these
forward-looking statements as a result of several factors,
including unexpected results or delays in the growth of the
Company's business, or in the development, regulatory review or
commercialization of the Company's partnered products, regulatory
approval requirements, unexpected adverse events or patient
outcomes and competitive conditions. These and other factors that
may result in differences are discussed in greater detail in the
Company's most recent Annual Report on Form 10-K and Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission.
Tecentriq® (atezolizumab) is a registered trademark
of Genentech, a member of the Roche Group.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
Shannia Coley
CG Life
443-471-6830
scoley@cglife.com
References
1. De Cock E, et al. A time and motion study of subcutaneous versus
intravenous trastuzumab in patients with HER2-positive early breast
cancer. Cancer Med. 2016;5(3):389-97.
2. O'Shaugnessy, J. Patient (pt) preference for the
pertuzumab-trastuzumab fixed-dose combination for subcutaneous use
(PH FDC SC) in HER2-positive early breast cancer (EBC): Primary
analysis of the open-label, randomized crossover PHranceSCa study.
Presented at ESMO; 19-21 Sept 2020.
Abstract #165MO.
3. Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab
and intravenous trastuzumab as part of adjuvant therapy for
HER2-positive early breast cancer: final analysis of the
randomized, two-cohort PrefHer study. Eur J Cancer.
2017;86:82-90.
4. Rummel M, et al. Preference for subcutaneous or intravenous
administration of rituximab among patients with untreated CD20+
diffuse large B-cell lymphoma or follicular lymphoma: results from
a prospective, randomized, open-label, crossover study (PrefMab).
Ann Oncol. 2017;28(4):836-842.
5. Denys H, et al. Safety and tolerability of subcutaneous
trastuzumab at home administration, results of the phase IIIb
open-label BELIS study in HER2-positive early breast cancer. Breast
Cancer Res Treat. 2020;181(1):97-105.
6. Anderson, K C, et al. Humanistic and economic impact of
subcutaneous versus intravenous administration of oncology
biologics. Future Oncol. 2019;15(28):3267-3281.
7. UK Electronic Medicines Compendium (EMC). Tecentriq: package
leaflet. Last updated 5 July 2022.
https://www.medicines.org.uk/emc/files/pil.8442.pdf. Accessed
April 2023.
8. UK EMC. Phesgo SC: package leaflet. Last updated 16 March 2022.
https://www.medicines.org.uk/emc/files/pil.11989.pdf. Accessed
April 2023.
9. UK EMC. Herceptin SC: package leaflet. Last updated 28 September 2021.
https://www.medicines.org.uk/emc/files/pil.3856.pdf. Accessed
April 2023.
10. UK EMC. MabThera: package leaflet. Last updated
24 January 2022.
https://www.medicines.org.uk/emc/files/pil.5333.pdf. Accessed
April 2023.
11. Franken M, et al. Hospital-based or home-based administration
of oncology drugs? Breast. 2020 Aug; 52: 71–77.
12. Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 (Part 2:
Randomized Phase III): Pharmacokinetics (PK), efficacy and safety
of atezolizumab subcutaneous (SC) vs intravenous (IV) in previously
treated locally advanced or metastatic non-small cell lung cancer
(NSCLC). Presented at ESMO IO; 7-9 Dec
2022. Abstract #61MO.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-approval-of-roches-tecentriq-subcutaneous-sc-with-enhanze-in-great-britain-301911904.html
SOURCE Halozyme Therapeutics, Inc.